RT Journal Article
SR Electronic
T1 F49 Enroll-HD clinical trial committee
JF Journal of Neurology, Neurosurgery & Psychiatry
JO J Neurol Neurosurg Psychiatry
FD BMJ Publishing Group Ltd
SP A39
OP A39
DO 10.1136/jnnp-2021-EHDN.92
VO 92
IS Suppl 1
A1 The Enroll-HD Platform Team
YR 2021
UL http://jnnp.bmj.com/content/92/Suppl_1/A39.3.abstract
AB The Enroll-HD Clinical Trial Committee (CTC) is the entry point for industry and academic sponsors seeking provision of high-quality clinical advice and guidance, and/or access to Enroll-HD platform operational support for conducting interventional therapeutic trials in Huntington’s Disease (HD). The CTC has so far provided advice and support to multiple small biotech and major pharmaceutical company partners working in HD.The CTC comprises an operational management team and an independent advisory committee composed of HD expert clinicians and scientists, and has 3 main remits: (i) provision of advice on protocol design and clinical development topics, with access to experts from within the CHDI Clinical Department (imaging, biomarkers, clinical outcomes, disease modelling) and/or independent HD experts from the CTC advisory panel; (ii) review of final protocols by independent HD experts to allow access to Enroll-HD platform operational support (e.g. in-silico feasibility, site identification, recruitment support; see Enroll-HD Platform resource poster); (iii) oversight of the HD Clinical Trial Site Certification Program, open to Enroll-HD and non-Enroll-HD sites with the capabilities and expertise to be considered suitable for HD clinical trials. A Site Certification application group assesses sites’ suitability against a set of basic generic industry-agreed criteria.